Associate Director Pharmacometrics

Leads the execution and delivery of pharmacometrics tasks on assigned projects within (early/full) clinical development. Together with the leadership, s/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on assigned projects.

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

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The Role

As an Associate Director Pharmacometrics you will drive the pharmacometrics strategy for clinical programs in multiple indications or a disease area. As well as organizing the strategy for addressing pharmacometrics issues in regulatory submissions and integrated evidence generation directly influencing drug development and adoption decisions with internal and external partners.

Key Accountabilities:

• You will provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge.
• You will Represent the Global Project Teams internally and externally as the pharmacometrics expert.
• You will develop, write, and execute pharmacometrics analysis plans, and deliver reports on results.
• You will define and drive pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions).
• You will represent PMX on all pharmacometrics aspects of the programs at global regulatory hearings/advisory committee meetings and other global regulatory interfaces.
• You will drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards. As well as Identify alternative strategic options to mitigate risk on clinical programs.
• You will lead and contribute to Integrated Evidence generation by leveraging disease progression and PKPD modeling techniques using varied data sources, including Real World Data.
• You will contribute to various internal and external initiatives on use of PMX techniques in support of Evidence Generation.
• You will ensure that the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometrics strategy, execution, and delivery of assigned projects.

Your Experience

• Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent).
• Experience in applying model-based methods in pre-clinical and clinical drug development.
• Track record of contributions to external whitepapers/ policy shaping best practice in pharmacometrics. Internally and externally established track record of developing/establishing pharmacometrics excellence.
• Experience in contributing to global scientific improvement/change initiatives.
• Scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy. Track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? :

Commitment to Diversity & Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.